MHRA seeks public views on no-deal Brexit

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is seeking industry views on a no-deal Brexit scenario.

In the event that the UK government and the EU are unable to reach a deal before the UK’s exit from the union, the agency is asking for views on how the MHRA’s legislation and regulatory processes would have to be modified.

The UK is on track to leave the EU on March 29, 2019.

Topics that the agency aims to address include proposals on medicines, clinical trials and medical devices.

According to the MHRA, the agency would take on the responsibility of being the sole regulator in protecting human and animal health in the UK.

“This would include decisions on marketing authorisation applications which are currently authorised through the centralised procedure, paediatric investigation plans and orphan status, as well as pharmacovigilance responsibilities,” said the agency.

Currently, this is the European Medicines Agency’s (EMA) obligation. However, in the event of a no-deal, the UK would fall outside of the EMA’s jurisdiction.

The consultation covers changes to four statutory instruments: the Medicines for Human Use (Clinical Trials) Regulations 2005; the Medical Devices Regulations 2002; the Human Medicines Regulations 2012; and the Medicines (Products for Human Use) (Fees) Regulations 2016.

Many of the changes to the statutory instruments would remove relevant references to the EU and make them more applicable to the UK.

The consultation will run for four weeks from October 11 to November 1, 2018.

Last month,  LSIPR  reported that the EMA has stopped giving any work to the MHRA.

Drugs that are sold in Europe must go through an EMA authorisation procedure and national regulators, such as the MHRA. However, under the changes, existing contracts with the MHRA are being reallocated to other EU member states.

For more information on the consultation, click here.

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